The general ability to detect pathogens on any of a variety of surfaces is desired. In food preparation, either in the commercial or home setting, the detection of pathogens on food preparation surfaces and the like is valuable to prevent cross-contamination of food items being prepared on the surface. Examples of contaminating materials may include bacteria, food products that contain bacteria (e.g. raw meat and its juices), or certain biological fluids. To prevent cross-contamination, it is desirable to determine the level of soil on certain surfaces such as household surfaces including kitchen and bathroom surfaces (e.g. counters, cutting boards, toilets) as well as room surfaces (e.g. floors, walls). In addition, an assessment of cleanliness is important for the surfaces of medical devices exposed to biological fluids during use. Examples of medical devices include the surfaces of endoscopes, catheters, and the like.
While kits are commercially available to test the cleanliness of certain surfaces, available kits typically require samples to be sent to an outside laboratory for analysis. The time involved in sending samples to an outside laboratory for analysis must be factored into the time required for the requester to receive a response. Additionally, culture methods are typically employed in the analysis for pathogens, thus requiring microbiology laboratory equipment and the expertise of trained microbiologists.
In health care fields, medical devices such as endoscopes, find utility in medical procedures that expose the devices to biological soil. Endoscopes, for example, are used in medical procedures within a patient's body in which the endoscope is inserted into the body either through a natural orifice or through a surgical opening. Endoscopes include a number of channels that may carry optical fibers for viewing areas in the body to facilitate the examination of organs, joints or body cavities and for conveying light to the area being viewed. Operating instruments such as electrosurgery probes or forceps may be passed through the channels of an endoscope, and the channels may also be used to deliver fluids or gas, or to provide suction or pass sampling catheters therethrough.
Virtually any part of the human body is accessible to an endoscope, and typical surgical sites include the ear, throat, urinary tract, lungs, intestines and the abdominal cavity. Endoscopes used in colonoscopy procedures permit the direct examination of the inside of the colon and large intestines for the presence of polyps, ulcers and inflammation. Foreign bodies such as polyps or tumors may be surgically removed through the endoscope.
As may be apparent, endoscopes and other medical devices are exposed to any of a variety of body soils during their uses in surgical procedures. Such soils include blood, fecal matter, cellular matter from various tissue, and the like, and any of these soils may provide sources of viruses or bacteria. Because of their use within the body, endoscopes must be thoroughly cleaned and disinfected following each use to ensure that all soiled surfaces are disinfected prior to using the medical device in subsequent medical or surgical procedures. In a cleaning process employed in the United States on reusable endoscopes, the soiled endoscope is initially cleaned during a manual cleaning step to remove as much soil as possible from the surfaces of the instrument. Thereafter, a high level disinfection step is performed on the manually cleaned endoscope to render it ready for reuse. Typically, the manual cleaning step is performed by scrubbing the instrument with a cleaning brush or similar instrument. The manual cleaning step is performed until the brush no longer appears to pick up soil from the surfaces of the instrument. In the absence of an effective manual cleaning process, residual soil may remain on the surfaces of the instrument so that a risk for bacterial contamination may remain, thus increasing the possibility that the subsequent high level disinfection process may not be effective. Currently, there is no standard test device or methodology that provides a rapid determination of the efficacy of the manual cleaning step.
It is desirable to facilitate an ability to evaluate the efficacy of a cleaning or disinfecting process for any of a variety of surfaces, including the surface of endoscopes and other medical devices. It is desirable to provide a method that avoids extended incubation periods and facilitates the rapid identification of residual soil or the presence of certain pathogens. It is also desirable to provide an article or device that can be used in the performance of the foregoing method.